Source: DGNews  |  Posted 2 years ago

By Deborah Brauser

ORLANDO, Fla -- November 23, 2009 -- A new, continuous-flow heart pump, or left
ventricular assist device, (CF-LVAD), improves survival for patients with
advanced heart failure more than the currently approved pulsatile-flow model
(PF-LVAD), according to a study presented here at the American Heart
Association (AHA) Scientific Sessions 2009.

The results of the HeartMate II Destination Therapy Trial were presented here
on November 17 during a Late-Breaking Clinical Trial session.

“The new [CF-LVADs] have significant advantages including a smaller size and
superior durability, and it operates quietly,” said Joseph G. Rogers, MD, Duke
Heart Failure Program at Duke University Medical Center, Durham, North
Carolina. “It also pumps blood continuously, which reduces the systolic blood
pressure.”

According to Dr. Rogers, patients diagnosed with advanced heart failure treated
with optimal medical therapy have a 10%-20% survival rate in the ensuing years.

Therefore, the primary endpoint for this study was “survival free from
disabling stroke and device failure requiring reoperation at 2 years,”
according to Dr. Rogers. Overall survival and functional capacity were
secondary outcomes.

A total of 200 patients (median age, 64 years; 85% male) ineligible for heart
transplantation were enrolled at 38 medical centres in the United States from
March 2005 to May 2007. They were randomised 2:1 to receive either a CF-LVAD (n
= 134) or PF-LVAD (n = 66).

Results showed that the number of CF-LVAD patients who reached the composite
primary endpoint was significantly greater than the PF-LVAD patients (46% vs
11%; P < .001).

The patients who received the CF-LVAD also had greater overall survival at
1-year (68% vs 55%) and 2-year follow-ups (58% vs 24%).

In addition, significantly fewer CF-LVAD patients needed surgery to repair or
replace the pump (10% vs 36%; P < .001).

The rate of disabling stroke was similar for both groups (11% for CF-LVAD and
12% for PF-LVAD).

“The results of this trial are such that the [CF-LVAD] should alter the manner
in which we provide mechanical circulatory support,” summarised Dr. Rogers. “In
fact, we believe that in the future there will be little need for pulsatile
blood pumps.”

Funding for this study was provided by the Thoratec Corporation.

Presentation title: Outcomes of Patients With Advanced Heart Failure
Treated With Either a Pulsatile or Continuous Flow Left Ventricular Assist
Device: Results of the HeartMate II Destination Therapy Trial. Abstract
LBCT-20018